| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06475742 | Long-term Safety and Tolerability of Cenerimod in Adults With Systemic Lupus Erythematosus | PHASE3 | ENROLLING BY_INVITATION | 680 | — | — | Jul 30, 2024 | May 1, 2028 | May 6, 2026 | 106 | United States, Argentina +21 |
| NCT05672576 | A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 451 | — | — | Jun 26, 2023 | May 1, 2027 | Apr 2, 2026 | 147 | United States, Chile +16 |
| NCT05648500 | A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus | PHASE3 | ACTIVE NOT_RECRUITING | 470 | — | — | Dec 13, 2022 | May 1, 2027 | May 6, 2026 | 198 | United States, Argentina +15 |
Occurrence of treatment-emergent adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).
Occurrence of serious adverse events up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period).
Occurrence of adverse events of special interest up to the final study visit (maximum 3 years of study treatment plus 6-month safety follow-up period). Adverse events of special interest include the anticipated risks of treatment with cenerimod, known class effects, and events that may be related to systemic lupus erythematosus comorbidities, i.e., adverse events related to: * Effects on heart rate and rhythm * Hypotension * Hypertension * Cardiovascular * Hepatobiliary disorders / liver enzyme abnormalities * Pulmonary * Eye disorders * Infections * Skin malignancies * Non-skin malignancies
Response on SRI-4 is defined as: * Reduction from baseline of at least 4 points in the modified Systemic Lupus Erythematosus Disease Activity Index-2000 score (mSLEDAI-2K \[SLEDAI-2K modified to exclude leukopenia, thus mSLEDAI-2K\]), and * No new British Isles Lupus Assessment Group-2004 (BILAG) A organ domain score and not more than one new BILAG B organ domain score compared to baseline, and * No worsening from baseline in subjects' lupus disease activity, where worsening is defined as an increase ≥ 0.30 points on a 3-point Physician's Global Assessment visual analog scale (PGA VAS), and * No violation of specified medication rules detailed in the core protocol.
| Arm | Type | Description |
|---|---|---|
| Cenerimod 4 mg | EXPERIMENTAL | Participants will receive oral cenerimod once daily in addition to background systemic lupus erythematosus therapy, for at least 1 year and up to a maximum of 3 years. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo once daily in addition to background SLE therapy. |
| Matching placebo | PLACEBO_COMPARATOR | Participants will receive matching placebo once daily in addition to background SLE therapy. |
| Name | Type | Description |
|---|---|---|
| Cenerimod | DRUG | Film-coated tablets at a dose of 4 mg. |
| Placebo | DRUG | Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod. |
Inclusion Criteria: 1. Signed and dated informed consent form prior to any study-mandated procedure. 2. Participants with a diagnosis of systemic lupus erythematosus who: * Completed the 12-month double-blind treatment period of either of the parent studies (ID-064A301, ID-064A302). * Did no...